Medical Devices FDA Guidance to Get Approved

Commercializing medical products requires careful navigation through the complex FDA and international regulations.

Medical Devices FDA Guidance

Get The Right Regulatory Guidance to Succeed

Boulder iQ has the expertise and experience to guide you through the challenging and expensive regulatory process to minimize risk with our thorough, and effective regulatory process understanding.

Navigating the FDA System

All medical device companies must register with the FDA. If they sell products in the United States, they must list their products. Boulder iQ can help you register your product with the FDA and ensure compliance with all regulations to sell your product in the U.S.

Nuance & Experience

Boulder iQ staff has the nuance and experience from decades of hands-on regulatory strategy and implementation experience; including former FDA and ISO submission reviewers on staff. We have successfully gained regulatory clearance for over 175 medical devices.

Notified Meetings & Audits

Boulder iQ will prepare all technical files required for all classes of medical devices for notified body meetings and audits. We have the expertise to prepare you to obtain an international CE mark and present information specific to each country’s requirements.

US Based Agents

If you are an international company exporting medical devices into the United States, you must have a US agent based in the United States to answer FDA and US Customs questions. Boulder iQ serves as a US agent for international companies, answering questions and helping address such issues as US Customs seizures and FDA inspection notifications. Boulder iQ can help you prepare for FDA inspections and audits with a mock FDA inspection and mock FDA audit.